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On April 13, 2005, a federal court in Salt Lake City [U.S. District Court for the District of Utah, Central Division] issued its decision on a legal challenge to FDA’s 2004 Final Rule banning all ephedrine-alkaloid dietary supplements. Judge Tena Campbell’s decision made two key points:
1) It held that the analysis used by FDA was incorrect and improper. FDA’s analysis weighed risks against benefits. The Dietary Supplement Health and Education Act (DSHEA), however, requires a straightforward risk assessment. The court held that requiring supplement companies to demonstrate a benefit as a pre-condition to marketing violated DSHEA by shifting the burden from FDA to industry. [This issue was explored in a 2004 article I co-authored with Alan Feldstein, Esq., and published in the Sports Nutrition Review Journal (available in the Articles section of this site).]
2) It held that FDA didn’t have adequate scientific evidence to find that a daily dose of 10 mg. or less of ephedrine alkaloids presented a “significant or unreasonable risk of illness or injury” [under 21 U.S.C. § 342(f)(1)(A)]. The court effectively held that it’s improper to ban all ephedra supplements because FDA lacks data to determine what dosage might be safe.
The case isn’t necessarily over yet. FDA has filed a notice of appeal, and the 10th Circuit Court of Appeals might reverse the district court’s ruling. However, FDA did not seek a stay to block renewed ephedra sales while the matter is pending.
So where does this leave ephedra supplements? My firm has been besieged by calls from curious supplement manufacturers seeking advice. Some aggressive supplement companies have already renewed online ephedra product sales. But companies contemplating a return to the ephedra market should first discuss the issue with knowledgeable legal counsel familiar with what may well be a fluid and changing landscape. The Utah decision should not be viewed as carte blanche for everyone to sell ephedra products. The scope of the decision has yet to be clarified, and legal minds can differ as to how “narrowly” to interpret the ruling. For example, the narrowest interpretation would be that the decision only applies to the products made by the company involved in the lawsuit, since those were the only products that were specifically the subject of the suit. One trade association has already voted to require a pledge not to sell ephedra products at any dose as a condition of membership. Certainly, before any company proceeds, there are at least four issues which must be considered:
• Dosage. The ruling only addresses low-dose products (10 mg. or less daily). Many ephedra supplements prior to the ban contained up to 100 mg. in total daily dosage. Significantly, a New Jersey lawsuit claiming that FDA didn’t demonstrate unreasonable risk with respect to higher dose ephedra products was resolved last year in FDA’s favor. The ban remains in place for high-dose products.
• Jurisdiction. FDA may interpret the ruling as binding only in the court’s Utah district, and could take action against ephedra products in other jurisdictions. In fact, FDA did exactly that in the early 1990s with respect to black currant oil capsules. When the agency lost in a Chicago court, it took action in a Boston court for sale of the same product. Also, the federal court decision doesn’t preempt state laws banning ephedra, so sales would still be illegal in states such as California, Illinois, New York, and other states which may pass anti-ephedra legislation.
• Importation. Companies seeking to reenter the market also need to think about how to obtain the raw materials. The embargo against importing ephedra is not voided by the ruling. FDA may take enforcement action against companies seeking to import the ingredient.
• Products liability. The court ruled that FDA failed to prove that low doses of ephedra are dangerous, but did not affirmatively rule that low doses of ephedra are safe. “Prior to the FDA ban, the ephedra supplement market was being crushed by the spiraling costs of product liability insurance – and the refusal by some carriers to insure ephedra products at all,” points out Alan Feldstein, an authority on ephedra supplements and Of Counsel to my law firm, Collins, McDonald & Gann. “Also, this ruling will probably not stop trial lawyers from continuing to bring suits alleging ephedra products are inherently dangerous,” adds Feldstein.
Predictably, anti-supplement activists are denouncing the decision. A senior policy analyst for the Consumers Union, publisher of Consumer Reports, shrieked: “This is just nuts. Bringing ephedra back to market even at low doses is dangerous.” But the decision may have key implications beyond ephedrine alkaloids. Critics have renewed their cries to repeal or reform DSHEA, saying that the ruling is evidence that DSHEA prevents FDA from pulling dangerous products from store shelves. The watchdog group Public Citizen claims DSHEA has been a “disaster” and should be repealed. The New York Times ran an editorial urging the White House and Congress “to move promptly to enact overdue legal revisions that will significantly strengthen [FDA’s] power to monitor and police the supplement industry.” Voices from Capitol Hill are joining the chorus. “If FDA can’t take a supplement as dangerous as ephedra off the market, then Congress needs to change the law to allow it to do so,” Sen. Edward Kennedy (D-Mass.) said through a spokeswoman. Rep. Henry Waxman (D-Cal) wants to revisit DSHEA to “give FDA the authority it needs to protect American consumers from dangerous supplements.” [Industry members concerned about the reinvigorated attack on DSHEA and seeking advice on what to do about it should feel free to call my office.]
But not everyone’s jumping on the anti-ephedra bandwagon. “While ephedra might be more dangerous than, say, a multivitamin, its risks, which stem mainly from stimulating the cardiovascular system, are well within the range considered acceptable for OTC [over-the-counter] drugs,” points out syndicated columnist Jacob Sullum in a recent Washington Post article. “The FDA, the medical establishment and the pharmaceutical industry all want to prevent emergence of an alternative drug market in which consumers can obtain cheap, effective and reasonably (though not completely) safe products without permission from the government’s gatekeepers.”
Will consumers see low-dose ephedra supplement products return to the shelves soon? Quite possibly, but the long-term future of this supplement remains shrouded in uncertainty. For specific advice to industry based on the latest developments regarding ephedra, contact my law firm at 516-294-0300 or [email protected].
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